In Malaysia, general medical and IVD devices are regulated by the Medical Device Authority (MDA) of the Ministry of Health. The regulatory framework is based on the Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012 and closely follows GHTF guidelines. The legislation came into effect on July 1, 2013. Prior to that time, there was a voluntary registration system in place.
The MDA ultimately approves or rejects medical device applications.
A list of MDA regulations can be found here on our website.
我们的专家将详细解读2023年韩国食品药品安全部（MFDS）指导文件草案更新下韩国医疗器械注册监管要求、分类标准、韩国良好生产规范（KGMP）等相关要求，并将依据多年韩国本地注册经验提供注册案例分享。此外，您还将了解到制造商在面对MFDS监管时需要关注的核心要点，相关研讨会内容包括：
阅读更多医疗器械和体外诊断（IVD）器械制造商需要在COFEPRIS注册他们的产品，COFEPRIS是墨西哥卫生部（Secretaría de Salud）的一个机构。器械在上市前需要上市前审批，豁免的器械除外。
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